Evidence map›Paper›PMID 34028598›Full record

Trial reportCancer chemotherapy and pharmacology2021

Phase II study of trifluridine/tipiracil (TAS-102) therapy in elderly patients with colorectal cancer (T-CORE1401): geriatric assessment tools and plasma drug concentrations as possible predictive biomarkers.

Masanobu Takahashi, Yasuhiro Sakamoto, Hisatsugu Ohori, Yasushi Tsuji, Michio Kuroki, Satoshi Kato, Kazunori Otsuka, Keigo Komine, Masahiro Takahashi, Shin Takahashi and 11 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
0.8field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 9 institutions in 1 country.

Masanobu TakahashiDepartment of Medical Oncology, Tohoku University Hospital, Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Yasuhiro SakamotoDepartment of Medical Oncology, Osaki Citizen Hospital, 3-8-1 Honami, Furukawa, Osaki, Miyagi, 989-6183, Japan.
Hisatsugu OhoriDepartment of Clinical Oncology, Japanese Red Cross Ishinomaki Hospital, 71 Hebitanishimichishita, Ishinomaki, Miyagi, 986-8522, Japan.
Yasushi TsujiDepartment of Medical Oncology, Tonan Hospital, 7-3-8 kitashijonishi, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan.
Michio KurokiDepartment of Gastroenterology, Yamagata City Hospital Saiseikan, 1-3-26 Nanukamachi, Yamagata, Yamagata, 990-8533, Japan.
Satoshi KatoDepartment of Medical Oncology, Iwate Prefectural Central Hospital, Ueda 1-1-1, Morioka, Iwate, 020-0066, Japan.
Kazunori OtsukaDepartment of Medical Oncology, Miyagi Cancer Center, Nodayama 47-1, Medeshima, Natori, 981-1293, Japan.
Keigo KomineDepartment of Medical Oncology, Tohoku University Hospital, Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Masahiro TakahashiDepartment of Medical Oncology, Tohoku University Hospital, Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Shin TakahashiDepartment of Medical Oncology, Tohoku University Hospital, Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Hidekazu ShirotaDepartment of Medical Oncology, Tohoku University Hospital, Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Kota OuchiDepartment of Medical Oncology, Osaki Citizen Hospital, 3-8-1 Honami, Furukawa, Osaki, Miyagi, 989-6183, Japan.
Yoshikazu TakahashiDepartment of Medical Oncology, Osaki Citizen Hospital, 3-8-1 Honami, Furukawa, Osaki, Miyagi, 989-6183, Japan.
Hiroo ImaiDepartment of Clinical Oncology, Japanese Red Cross Ishinomaki Hospital, 71 Hebitanishimichishita, Ishinomaki, Miyagi, 986-8522, Japan.
Hiroyuki ShibataDepartment of Clinical Oncology, Graduate School of Medicine, Akita University, Hondo 1-1-1, Akita, 010-8543, Japan.
Takashi YoshiokaDepartment of Clinical Oncology, Yamagata University School of Medicine, Iida-nishi 2-2-2, Yamagata, 990-9585, Japan.
Masaki TanakaDepartment of Pharmaceutical Sciences, Tohoku University Hospital, Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Hiroaki YamaguchiDepartment of Pharmaceutical Sciences, Tohoku University Hospital, Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Takuhiro YamaguchiDivision of Biostatistics, Tohoku University Graduate School of Medicine, Seiryo-machi 2-1, Aoba-ku, Sendai, Miyagi, 980-8575, Japan.
Hideki ShimodairaDepartment of Medical Oncology, Tohoku University Hospital, Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Chikashi IshiokaDepartment of Medical Oncology, Tohoku University Hospital, Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, 980-8574, Japan. chikashi@tohoku.ac.jp.ORCID http://orcid.org/0000-0002-3023-1227
Tohoku University · JPOsaki Citizen Hospital · JPTohoku University Hospital · JPAkita University · JPIwate Prefectural Central Hospital · JPMiyagi Prefectural Hospital Organization · JPTonan Hospital · JPYamagata City Hospital Saiseikan · JPYamagata University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe current study aimed to determine the efficacy of trifluridine/tipiracil for elderly patients with advanced colorectal cancer.

methodsThis single-arm, open-label, multicenter, phase II study included elderly patients aged 65 years or more who had fluoropyrimidine-refractory advanced colorectal cancer and received trifluridine/tipiracil (70 mg/m

resultsA total of 30 patients with a mean age of 73 years were enrolled. Median PFS was 2.3 months (95% confidence interval, 1.9-4.3 months), while median OS was 5.7 months (95% confidence interval, 3.7-8.9 months). Patients had an ORR of 0%, with 57% having stable disease. Grade 4 neutropenia was observed in 13% of the patients. Patients with a higher G8 score (15 or more) showed longer PFS than those with a lower G8 score (median 4.6 vs. 2.0 months; p = 0.047). Moreover, patients with grade 3 or 4 neutropenia showed higher maximum trifluridine concentrations than those with grade 1 or 2 neutropenia (mean 2945 vs. 2107 ng/mL; p = 0.036). DISCUSSION: The current phase II trial demonstrated that trifluridine/tipiracil was an effective and well-tolerated option for elderly patients with advanced colorectal cancer. Moreover, geriatric assessment tools and/or plasma drug concentration monitoring might be helpful in predicting the efficacy and toxicities in elderly patients receiving this drug. TRIAL REGISTRATION NUMBER: UMIN000017589, 15/May/2015 (The University Hospital Medical Information Network).

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorColorectal NeoplasmsDrug CombinationsDrug MonitoringFemaleGeriatric AssessmentHumansMaleNeutropeniaProgression-Free SurvivalPyrrolidinesSurvival RateThymineBiomarkers, TumorDrug CombinationsPyrrolidinesThymineTrifluridinetrifluridine tipiracil drug combinationColorectal cancerG8Geriatric assessmentPlasma concentrationTipiracilTrifluridine

Identifiers

PMID34028598
PMCPMC8316169
OpenAlexW3164196732

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.